HOLOGIC, INC. – $113,963.00/Year

Requires a Masters degree in Healthcare Technologies Management, Biomedical Engineering, or related field plus 6 years of experience in the medical device industry and FDA regulated environment. Employer will also accept a Ph.D. in Healthcare Technologies Management, Biomedical Engineering, or related field plus 3 years of experience in the medical device industry and FDA regulated environment. Experience must include 3 years of experience with each of the following 1 FDA cGMP manufacturing requirements; 2 ISO 14971 for Risk Management, FDA Quality System Regulation, and ISO 13485 quality system standards; 3 authoring, developing and approving Installation Qualification IQ, Operational Qualification OQ, Performance Qualification PQ, Test Method Validation TMV procedures, protocols and reports; 4 Continuous Improvement Lean; 5 PPAP elements including Process Flow, PFMEA, Control, Inspection Plans, MSA, Gage RR, Process, Test Method and Process Validations, Process Capability Studies, and statistical analysis tools including Minitab; and 6 New Product Development from initial concept to commercialization.